Research Journal of Pharmacy and Technology

Mukthinuthalapati Mathrusri Annapurna ¹, Bukkapatnam Venkatesh ¹, Sunkara Mrunal Chaitanya ¹

Affiliations
1 Department of Pharmaceutical Analysis and Quality Assurance, GITAM Institute of Pharmacy, GITAM University, Visakhapatnam-530045, IN

Abstract

Cabazitaxel is used in the treatment of hormone-refractory prostate cancer. It is a semisynthetic taxane that can be used as a precursor molecule obtained from yew tree needles. The authors have developed a stability indicating liquid chromatographic method for the determination of Cabazitaxel in pharmaceutical products. Shimadzu Model CBM-20A/20 Alite HPLC system (PDA detector) with Zorbax SB C₁₈ column (150 mm × 4.6 mm i.d., 3.5 μm particle size) was selected for the quantification of Cabazitaxel. A mixture of tetra butyl ammonium hydrogen sulphate and methanol was used as the mobile phase with a flow rate of 1.0 mL/min (UV detection at 210 nm). The proposed analytical method was statistically validated and forced degradation studies were conducted. Cabazitaxel has shown linearity over the concentration range 0.1-200 μg/mL with regression equation y = 26145x + 22943 (r²=0.9997) and considerable degradation was observed in acidic, alkaline and oxidation conditions. The method is specific as the resolution of Cabazitaxelwas good in presence of its degradation products. This validated stability indicating liquid chromatographic method can be used for the determination of Cabazitaxel in biological studies as well as for the pharmaceutical products.

Keywords

Cabazitaxel, RP-HPLC, Tetra Butyl Ammonium Hydrogen Sulphate, Validation, Stabilityindicating.

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Mukthinuthalapati Mathrusri Annapurna ¹, Bukkapatnam Venkatesh ¹, Angirekula Narendra ¹

Affiliations
1 Department of Pharmaceutical Analysis and Quality Assurance, GITAM Institute of Pharmacy, GITAM University, Visakhapatnam-530045, IN

Abstract

Agomelatine is an anti-depressent drug. A new simple stability indicating reverse phase liquid chromatographic method has been established for the determination of Agomelatine in presence of an internal standard. Agomelatine is used for the treatment of prostate cancer. The proposed work has been performed on Shimadzu Model CBM-20A/20 Alite with Phenomenex C18 column (250 mm × 4.6 mm i.d., 5 μm particle size) using 0.1% formic acid and acetonitrile mixture as the mobile phase with flow rate 0.6 ml/min (UV detection at 205 nm). The method was validated as per ICH guidelines and the regression equation was found to be y = 0.2084x - 0.0475. Agomelatine was subjected to acidic, alkaline, oxidation, UV and thermal stress degradations and the method was reported to be robust and specific and can be applied for the assay of pharmaceutical formulations.

Keywords

Agomelatine, RP-HPLC, Validation, Stability-Indicating, Bimatoprost.

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